e13fea4e-bd6d-425a-aa7e-1d41dc36bf00

SPL v4
SPL
SPL Set ID e13fea4e-bd6d-425a-aa7e-1d41dc36bf00
Route
topical
Published
Effective Date 2025-04-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
petrolatum (30 g)
Inactive Ingredients
water glycerin glyceryl stearate peg-100 stearate stearic acid polyoxyl 20 cetostearyl ether sodium hydroxide lanolin alcohols carbomer copolymer type a (allyl pentaerythritol crosslinked) phenoxyethanol triethylene glycol .alpha.-tocopherol acetate edetate disodium

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph drug active Since 2021-02-01

Purpose

Skin Protectant

Description

White Petrolatum USP


Medication Information

Warnings

For external use only.

Do not use on:

  • deep puncture wounds
  • animal bites
  • serious burns.

When using this product, do not get into eyes.

Stop use and ask a doctor if:

•condition worsens

•symptoms last more than 7 days or clear up and occur again within a few days

Uses
  • temporarily protects minor: cuts, scrapes and burns
  • temporarily protects and helps relieve chapped or cracked skin
  • helps protect from the drying effects of wind and cold weather
Purpose

Skin Protectant

Directions

apply as needed.

Inactive Ingredients

water, glycerin, glyceryl stearate, PEG—100 stearate, stearic acid, ceteareth-20, sodium hydroxide, lanolin alcohol, fragrance, acrylates/C10-30 alkyl acrylate crosspolymer, phenoxyethanol, triethylene glycol, tocopheryl acetate, disodium EDTA

Description

White Petrolatum USP

Section 51945-4

Active Ingredient

White Petrolatum USP

Keep Out of Reach of Children

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Warnings

For external use only.

Do not use on:

  • deep puncture wounds
  • animal bites
  • serious burns.

When using this product, do not get into eyes.

Stop use and ask a doctor if:

•condition worsens

•symptoms last more than 7 days or clear up and occur again within a few days

Uses
  • temporarily protects minor: cuts, scrapes and burns
  • temporarily protects and helps relieve chapped or cracked skin
  • helps protect from the drying effects of wind and cold weather
Purpose

Skin Protectant

Directions

apply as needed.

Inactive Ingredients

water, glycerin, glyceryl stearate, PEG—100 stearate, stearic acid, ceteareth-20, sodium hydroxide, lanolin alcohol, fragrance, acrylates/C10-30 alkyl acrylate crosspolymer, phenoxyethanol, triethylene glycol, tocopheryl acetate, disodium EDTA

Section 51945-4 (51945-4)

Active Ingredient

White Petrolatum USP

Keep Out of Reach of Children (Keep out of reach of Children)

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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